The goal for this study is to evaluate the efficacy and safety of RAY1225 versus placebo in participants with type 2 diabetes not under control with diet and exercise alone.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Have been diagnosed with type 2 diabetes mellitus (T2DM)
2. Having received only dietary and exercise therapy and never taken any antihyperglycemic medications before screening; OR Having taken no antihyperglycemic medications within the 12 weeks before screening and, prior to that, having received only oral antihyperglycemic drugs in a regimen of no more than two concomitant agents.
3. Have a body mass index (BMI) ≥20 kilograms per meter squared (kg/m²) at screening
4. Be of stable weight (±5%) for at least 12 weeks before screening
Exclusion Criteria:
1. Have type 1 diabetes mellitus
2. Presence of severe chronic diabetic complications at screening, including but not limited to: proliferative diabetic retinopathy, diabetic macular edema, and severe non-proliferative diabetic retinopathy requiring acute treatment;
3. History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;
4. Occurrence of a Grade 3 hypoglycemic event within 12 months prior to screening, or ≥3 Grade 2 hypoglycemic events (venous or capillary blood glucose \<3.0 mmol/L) within 3 months prior to screening, or presence of hypoglycemia-related symptoms ;
5. History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;
6. Receipt of blood transfusion within 12 weeks prior to screening, or blood donation/loss ≥400 mL within 12 weeks prior to screening, or blood donation/loss ≥200 mL within 4 weeks prior to screening, or known hemoglobinopathy (such as thalassemia, hemolytic anemia, sickle cell anemia, etc.);
7. Any unstable or treatment-requiring endocrine disorders related to glycemic control other than type 2 diabetes mellitus (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.).
Primary outcome measure(s)
Change From Baseline in Hemoglobin A1c (HbA1c) — Baseline,36 Week HbA1c is the glycosylated fraction of hemoglobin A.
Trial sites (1)
Facility
City
Region
Status
Peking University People's Hospital
Beijingcun
Hebei
More Guangdong Raynovent Biotech Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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